Phase II Trial of preoperative Therapy with gefitinib and chemotherapy in Patients with ERneg Breast Cancer

Study identifier:1839IL/0712

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Randomised Placebo-controlled Phase II Trial of preoperative Therapy with gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients with primary operable (T2-T3) Oestrogen Receptor negative Breast Cancer

Medical condition

Breast Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

gefitinib

Sex

Female

Actual Enrollment

160

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Oct 2004
Primary Completion Date: 01 May 2007
Study Completion Date: 01 May 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria